Oral data collection device

ABSTRACT

The present disclosure provides an oral data collection device comprising a mouthguard and at least two sensors, a medical analytics system comprising the device, and methods of using the device and system to provide a personalized treatment protocol, stage a health condition, measure a response to therapy, phenotype for selection to participate in drug trials, measure stability of an anatomical structure, or predict a rate of change of a health condition in a subject in need thereof.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/900,885, filed Sep. 16, 2019, the contents of which are incorporatedherein by reference in their entirety.

FIELD OF THE INVENTION

The present disclosure provides an oral data collection device, amedical analytics system, and methods of using the device and system.

BACKGROUND OF THE INVENTION

Significant medical advancements in conjunction with higher computingpower, lower hardware cost, and improved data management have led to anapproach using a medical analytics approach to healthcare to be moreholistically understood. In this era, there is a great deal of interestin wearable devices with functionality to collect up-to-date real-timehealth data.

Within the oral region of the human body, there are many otheropportunities for the collection of invaluable health indicators. Forinstance, concern about injuries that occur during sporting activitieshas increased. In particular, head traumas that can result in concussionhave come under greater scrutiny. According to the US Centers forDisease Control and Prevention (CDC), more than 3.8 million sports braininjuries occur per year with 300,000 resulting in loss of consciousness(LoC). These injuries are not limited to occurrence at the professionalor collegiate level, but also include an estimated number of 25,000sports brain injuries occurring at the high school level. Diagnosis andtreatment of such injuries can be enhanced by monitoring athletes duringthe sporting events that can result in concussions and other headinjuries. Importantly, oral health data can also be used to diagnose,monitor, and treat health conditions in a subject. For instance, oraldata during sleep can provide invaluable information on a number of oralconditions and other health conditions that exhibit in data collected inthe oral cavity, including bruxism, xerostomia, and PTSD. However, todate, there are no capabilities to continuously measure oral data duringsleep. For instance, besides using the symptoms of bruxism that may beexhibited in the subject, including headaches, muscle soreness, daytimejaw discomfort/wear, and stress, methods of diagnosing or tracking thedevelopment of bruxism do not currently exist.

Accordingly, there is a need in the art for devices, systems, andmethods of collecting oral data, especially oral data in the fitness andsports field, as well as when a subject is sleeping.

SUMMARY OF THE INVENTION

One aspect of the present disclosure encompasses an oral data collectiondevice comprising a mouthguard and sensors. The mouthguard comprises anarch-shaped body comprising a proximal end, a first distal end, and asecond distal end, an external surface, an internal surface, a firstbiting surface, and a tray operable to engage the upper or lower teethof a subject, the tray comprising a second biting surface opposite thefirst biting surface. The device further comprises two or more sensorsin the body of the mouthguard. The sensors comprise one or more pressuresensors, wherein each sensor is operable to sense biting force exertedby the upper and lower teeth of the subject at the first and secondbiting surfaces. The sensors also comprise a humidity sensor operable tosense relative humidity in the breath of a user wearing the device. Asensing surface of the humidity sensor can be at the internal surfaceoff center of the proximal end of the mouthguard.

The device further comprises a controller in the body of the mouthguard,wherein the controller is in functional communication with the two ormore sensors, and wherein the controller is operable to receive andcommunicate sensor data; a means for communication enclosed within thebody of the mouthguard, wherein the means for communication is operableto receive the sensor data from the controller and communicate thesensor data to a secondary device; and a power source functionallycoupled to the controller and the one or more sensors.

The device can comprise a first pressure sensor at the first distal endof the body of the mouthguard and a second pressure sensor at the seconddistal end of the body of the mouthguard. In some aspects, the pressuresensor is a pressure sensor stack. In some aspects, the device comprisesa first pressure sensor stack at the first distal end of the mouthguardand a second pressure sensor stack at the second distal end of themouthguard. The pressure sensor can be a force plate pressure sensor.Further, the pressure sensor can measure and withstand at least apressure ranging from about 1 to about 5000 kPa, from about 100 to about4000 kPa, or from about 100 to about 2000 kPa.

The device can further comprise a temperature sensor, a microphone orvibration sensor, an oxygen sensor, a nine-axis inertial sensor, a pH orother biochemical sensor, or combinations thereof. The nine-axisinertial sensor can be enclosed in the body of the mouthguard, andcomprises a three-axis magnetometer, a three-axis accelerometer, and athree-axis gyroscope, the three-axis magnetometer operable to provide areference plane in relation to earth's magnetic field for the three-axisaccelerometer and the three-axis gyroscope, wherein the nine-axisinertial sensor is adapted to sense a position and movement of the headand body of a user.

When the device comprises a temperature sensor, humidity sensor, andoxygen sensor, the temperature sensor, humidity sensor, and oxygensensor can be an integrated temperature, humidity, and oxygen sensor.The microphone or vibration sensor can be enclosed in an acousticchamber in the body of the mouthguard.

The means of communication can comprise a transmitter operable tocommunicate sensor data to the secondary device wirelessly using awireless communication protocol. The secondary device can be a desktopcomputer, a mobile computing device, a wearable device, a personaldigital assistant, a computing device with no user interface, acloud-computing platform, or a combination thereof. The power source canbe a rechargeable battery.

In some aspects, the device further comprises a protective compartmenthousing one or more of the sensors, the controller, the means forcommunication, and the power source.

Another aspect of the present disclosure encompasses an oral datacollection device. The device comprises a mouthguard comprising anarch-shaped body comprising a proximal end, a first distal end, and asecond distal end, an external surface, an internal surface, a firstbiting surface, and a tray operable to engage the upper or lower teethof a subject, the tray comprising a second biting surface opposite thefirst biting surface. The device further comprises sensors in the bodyof the mouthguard, the sensors comprising a first pressure sensor stackat the first distal end of the mouthguard and a second pressure sensorstack at the second distal end of the mouthguard, wherein each pressuresensor stack comprises a first pressure sensor and a second pressuresensor arranged in a stack; a humidity sensor operable to sense relativehumidity in the breath of a user wearing the device; and a microphone orvibration sensor.

The device further comprises a controller in the body of the mouthguard,wherein the controller is in functional communication with the sensors,and wherein the controller is operable to receive and communicate sensordata; a means for communication in the body of the mouthguard, whereinthe means for communication is operable to receive the sensor data fromthe controller and communicate the sensor data to a secondary device;and a power source functionally coupled to the controller and the one ormore sensors.

Yet another aspect of the present disclosure encompasses medicalanalytics system comprising an oral data collection device and asecondary device comprising at least one processor and associated memoryadapted to receive sensor data collected by the data collection device,and instructions which, when executed by the at least one processor,cause the at least one processor to interpret the sensor data obtainedfrom a subject into descriptive factors indicative of a health conditionof the subject; and output the descriptive factors. The descriptivefactors indicative of a health condition of the subject can comprisehydration, breathing patterns, body temperature, body and head position,body and head movement, clenching of the jaws, sleep phase, andnighttime mouth position.

The secondary device can further comprise instructions which, whenexecuted by the at least one processor, cause the at least one processorto provide a personalized treatment protocol, stage a health condition,measure a response to therapy, phenotype for selection to participate indrug trials, measure stability of an anatomical structure, or predict arate of change of a health condition in the subject.

An additional aspect of the present disclosure encompasses a method ofdetermining a personalized treatment protocol, staging a given healthcondition, measuring response to therapy, phenotyping for selection toparticipate in drug trials, measuring stability of an anatomicalstructure, or predicting rate of change of a health condition in asubject in need thereof. The method comprises providing or havingprovided the device described above to the subject for wearing by thesubject during sleep, and interpret the sensor data obtained from thesubject into descriptive factors indicative of a health condition of thesubject to determine the personalized treatment protocol, stage thegiven health condition, measure response to therapy, phenotype forselection to participate in drug trials, measure stability of ananatomical structure, or predict rate of change of a given healthcondition in the subject.

The method can further comprise providing a secondary device comprisingat least one processor and associated memory adapted to receive sensordata collected by the data collection device, and instructions which,when executed by the at least one processor, cause the at least oneprocessor to interpret the sensor data obtained from the subject intodescriptive factors indicative of a health condition of the subject; andoutput the descriptive factors.

The descriptive factors indicative of a health condition of the subjectcan comprise hydration, breathing patterns, body temperature, body andhead position, body and head movement, clenching of the jaws, sleepphase, and nighttime mouth position. The secondary device can furthercomprise instructions which, when executed by the at least oneprocessor, cause the at least one processor to provide the personalizedtreatment protocol, stage the health condition, measure the response totherapy, phenotype for selection to participate in drug trials, measurestability of an anatomical structure, or predict the rate of change of ahealth condition in the subject.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a top right perspective view of the device.

FIG. 2 is a bottom right perspective view of the device.

FIG. 3 is a top left perspective view of the side of the device with thetop biting surface removed thus exposing the components enclosed in thedevice.

FIG. 4 is a top left perspective view of the front of the device withthe top biting surface removed thus exposing the components enclosed inthe device.

FIG. 5 is a top view of the device with the top biting surface removedthus exposing the components enclosed in the device.

FIG. 6 is a top perspective view of the back of the device with the topbiting surface removed thus exposing the components enclosed in thedevice.

FIG. 7 is a perspective view of the back of the device with the topbiting surface removed thus exposing the components enclosed in thedevice with an exploded view of the components of the device in theprotective enclosure.

DETAILED DESCRIPTION

The devices, systems, methods, and computer program products for oraldata collection will be understood from the accompanying drawings, takenin conjunction with the accompanying description. It is noted that, forpurposes of illustrative clarity, certain elements in various drawingsmay not be drawn to scale. Several variations of the system arepresented herein. It should be understood that various components,parts, and features of the different variations may be combined togetherand/or interchanged with one another, all of which are within the scopeof the present application, even though not all variations andparticular variations are shown in the drawings. It should also beunderstood that the mixing and matching of features, elements, and/orfunctions between various variations is expressly contemplated herein sothat one of ordinary skill in the art would appreciate from thisdisclosure that the features, elements, and/or functions of onevariation may be incorporated into another variation as appropriate,unless described otherwise.

Provided herein are systems, devices, methods, and computer programproducts for collecting oral data in the oral cavity of a subject foruse in the healthcare field. The device can be worn by the user tocontinuously collect oral data normally not accessible to the user(s) ora designated official or healthcare professional. For instance, thedevice can be worn by a subject to collect oral data during exercise andduring sleep.

The device is targeted for use in a method for determining apersonalized treatment protocol, staging a given health condition,measuring response to therapy, phenotyping for selection to participatein drug trials, measuring stability of an anatomical structure, orpredicting rate of change of a health condition in a subject in needthereof. The health conditions can be oral conditions as well as otherhealth conditions that exhibit in data collected in the oral cavity.Additionally, medical oral data collected by the device can be used aspart of a greater analytics medical network that incorporates machinelearning, predictive analytics, information sharing, medicalcommunications with professionals, and a virtual community where bigdata/trends are shared.

I. Device

One aspect of the present disclosure encompasses an oral data collectiondevice. The device comprises a mouthguard with two or more sensors, acontroller, a means for communicating sensor data, and a power source.The one or more sensors, controller, and power source are enclosed inthe body of the device.

The mouthguard comprises an arch-shaped body comprising an externalsurface, an internal surface, a first biting surface, and a trayoperable to engage a user's upper or lower teeth, the tray comprising asecond biting surface opposite the first biting surface. It will berecognized that the arch-shaped body and the tray are of a size andshape appropriate for engaging with, and securing the mouthguard to theteeth of a wearer.

Materials suitable for manufacturing the mouthguard will be apparent toan individual of skill in the art. For instance, materials for themouthguard may include, but are not limited to, one or more of thefollowing materials: plastic, rubber, gel, metal, ceramic, and glass.Further, the mouthguard can be manufactured using more than onematerial. For example, the tray of the mouthguard can be manufactured ofmaterial suitable for securing the mouthguard to the teeth, whereas thebody of the mouthguard can be manufactured using a material suitable forthe function and protection of elements enclosed within the body of themouthguard. The material could also be chosen to provide comfort for thewearer. Methods of manufacturing the mouthguard can and will varydepending on the material used for the product and the configuration ofthe product among other variables. For instance, the mouthguard can bemanufactured using blow molding methods.

The device comprises one or more pressure sensors in the body of themouthguard. Each sensor is operable to sense biting force exerted by theupper and lower teeth of the subject at the first and second bitingsurfaces. Pressure sensors are instruments or devices that translate themagnitude of the physical pressure exerted on the sensor into an outputsignal that can be used to establish a quantitative value for thepressure. There are many different types of pressure sensors known inthe art, which function similarly but rely on different underlyingtechnologies to make the translation between pressure and an outputsignal. Non-limiting examples of pressure sensor technologies include:

-   -   Potentiometric pressure sensors. Potentiometric pressure sensors        use a Bourdon tube, capsule, or bellows which drives a wiper        arm, providing relatively course pressure measurements.    -   Inductive pressure sensors. Inductive pressure sensors use a        linear variable differential transformer (LVDT) to vary the        degree of inductive coupling that occurs between the primary and        secondary coils of the transformer.    -   Capacitive pressure sensors. Capacitive pressure sensors use a        diaphragm that is deflected by the applied pressure, which        results in a change in the capacitance value, which can then be        calibrated to provide a pressure reading.    -   Piezoelectric pressure sensors. Piezoelectric pressure sensors        rely on the ability of materials such as ceramic or metalized        quartz to generate an electrical potential when the material is        subjected to mechanical stress.    -   Strain gauge pressure sensors. Strain gauge pressure sensors        rely on a measurement of the change in resistance that occurs in        a material such as silicon when it is subjected to mechanical        stress, known as the piezoresistive effect.    -   Variable reluctance pressure sensors. Variable reluctance        pressure sensors make use of a diaphragm that is contained in a        magnetic circuit. When pressure is applied to the sensor, the        diaphragm deflection causes a change in the reluctance of the        circuit and that change can be measured and used as an indicator        of the applied pressure.

A pressure sensor suitable for a device of the instant invention can beany pressure sensor having an appropriate size and shape suitable forfunctionally enclosing the sensor in the body of the mouthguard, andcapable of withstanding and measuring the entire range of a human'sbiting force, including the biting forces generated during bruxism.Biting during bruxism produces a pressure of about 100 lbs to 200 lbs(or about 2000 kPa). Accordingly, a pressure sensor of the disclosurecan measure and withstand at least a pressure ranging from about 1 toabout 5000 kPa, from about 100 to about 4000 kPa, or from about 100 toabout 2000 kPa.

A pressure sensor can be a membrane pressure sensor or a force platepressure sensor among others. In some aspects, the pressure sensor is aforce plate sensor. Force plate sensors use one of several differenttypes of sensors (load cells) to measure forces. Beyond vertical force,some force plate sensors can measure shear forces—i.e. lateral andhorizontal forces. In some aspects, the pressure sensor is a force platesensor. In some aspects, the pressure sensor is capable of measuringshear forces. In some aspects, the pressure sensor is a force platepressure sensor capable of measuring shear forces. Commerciallyavailable force plate pressure sensors suitable for use in a device ofthe invention include MD30-60 Resistance-Type Thin Film Pressure Sensor,and the FC2311-0000-2000-L Force Sensors & Load Cells high compressionload cell.

Pressure sensors suitable for the instant disclosure are operable toextrapolate velocity of movement (m/s), power (Watts), displacement(Meters), temporal parameters (seconds), and left/right asymmetry forbilateral systems. In conjunction with other measurements of the oralcavity of a subject such as 3D imaging of the oral cavity, force platepressure sensors can calculate and predict tooth location and movement,in addition to measuring the biting force. Such measurements can enablea frame-by-frame video/playback view of tooth location and movementthat, when mapped out over time, could predict the future state of oralhealth and placement, thereby allowing preventive measures to preventsuch movement or the damage resulting from these movements.

In some aspects, the device comprises one or more pressure sensors atthe first distal end of the body, one or more pressure sensors at thesecond distal end of the body, or one or more pressure sensors at thefirst distal end of the body and one or more pressure sensors at thesecond distal end of the body. Each sensor is operable to sense bitingforce exerted by the upper and lower molars of the subject at the firstand second biting surface. In some aspects, the device comprises apressure sensor at the first or second distal end of the mouthguard. Inother aspects, the device comprises a first pressure sensor at the firstdistal end of the mouthguard and a second pressure sensor at the seconddistal end of the mouthguard.

In some aspects, the pressure sensor is a pressure sensor stack.Accordingly, the device comprises one or more pressure sensor stacks.The pressure sensor stack comprises at least two sensors arranged in astack. In some aspects, the pressure sensor stack comprises a firstpressure sensor and a second pressure sensor, wherein the first sensoris operable to sense the biting pressure of a bottom molar, and thesecond sensor is operable to sense the biting pressure of a top molar.In some aspects, the device comprises one or more pressure sensor stacksat the first distal end of the body, one or more pressure sensor stacksat the second distal end of the body, or one or more pressure sensorstacks at the first distal end of the body and one or more pressuresensor stacks at the second distal end of the body. Each sensor isoperable to sense biting force exerted by the upper and lower molars ofthe subject at the first and second biting surface. In some aspects, thedevice comprises a pressure sensor stack at the first or second distalend of the mouthguard. In other aspects, the device comprises a firstpressure sensor stack at the first distal end of the mouthguard and asecond pressure sensor stack at the second distal end of the mouthguard.

The device also comprises a humidity sensor enclosed in the body of themouthguard. The humidity sensor is operable to detect relative humidityin the breath of a user wearing the device. A humidity sensor suitablefor a device of the instant invention can be any humidity sensor havingan appropriate size and shape suitable for functionally enclosing thesensor in the body of the mouthguard. Further, a humidity sensorsuitable for use in a device of the invention is generally waterproof tobe capable of measuring relative humidity in the breath of a user, inthe presence of saliva. Non-limiting examples of humidity sensorssuitable for a device of the invention include the HIH-4000-004 humiditysensor from Honeywell, and HDC 1080 sensors from Texas Instruments.

The humidity sensor is enclosed in the body of the mouthguard such thata sensing surface of the sensor is in physical contact with the breathof the wearer. Further, the humidity sensor is in a location in the bodyof the device such that a sensing surface of the sensor is in optimalcontact with exhaled or inhaled breath. For instance, a sensing surfacecan be in a cavity in the body of the mouthguard adjacent to, and infunctional communication with an aperture extending from the externalsurface to the internal surface at the proximal end of the body of themouthguard, wherein at least the sensing surface of the sensor is incontact with the breath of the user. Alternatively, the sensing surfaceis at the surface of the mouthguard at a location in the mouthguardcapable of providing optimal contact with exhaled breath. For instance,the sensing surface can be at the internal surface of the mouthguard. Insome aspects, a sensing surface of the humidity sensor is located offcenter at the internal surface of the proximal end of the mouthguard. Inone aspect, the sensing surface of the sensor is located at left ofcenter at the internal surface of the proximal end of the mouthguard. Inanother aspect, the sensing surface of the sensor is located right ofcenter at the internal surface of the proximal end of the mouthguard.

A suitable humidity sensor can sense relative humidity in a rangeencompassing the relative humidity of the breath, including the lowrelative humidity of a user with xerostomia or halitosis. Xerostomia ordry mouth is a common, but sometimes overlooked, condition that istypically associated with salivary gland hypofunction (i.e., theobjective measurement of reduced salivary flow). Reduced salivary flowcan cause difficulties in tasting, chewing, swallowing, and speaking; itcan also increase the chance of developing dental decay,demineralization of teeth, tooth sensitivity, and/or oral infections.There are a variety of potential causes of xerostomia, including adverseeffects of medication, toxicity of chemotherapy and/or radiation therapyof the head and neck, autoimmune disease, other chronic disease, andnerve damage. Halitosis—or chronic bad breath—is something that mints,mouthwash or a good brushing cannot solve. Unlike “morning breath” or astrong smell that lingers after a tuna sandwich, halitosis remains foran extended amount of time and may be a sign of something more serious.Halitosis can be an indication of health conditions in the subject,including cavities and gum disease, mouth, nose and throat infections,dry mouth including xerostomia, smoking, tobacco, or other chronicconditions such as gastric reflux, diabetes, and liver or kidneydisease.

Within the oral region of the human body there are many otheropportunities for invaluable human information and health indicators tobe more holistically understood. Accordingly, the device can furthercomprise sensors for use in collecting oral data in addition to bitingpressure and relative humidity in the breath. Non-limiting examples ofsensors include a temperature sensor, a microphone or vibration sensor,an oxygen sensor, a nine-axis inertial sensor, a pH or other biochemicalsensor, or combinations thereof. Such sensors are known in the art, andsuitable sensors can be identified experimentally. Other sensors capableof sensing oral biometric data are apparent to an individual of skill inthe art.

In some aspects, the device comprises a temperature sensor. Bodytemperature has been measured orally for centuries, but has not beenmeasured during sleep to measure parameters collected in conjunctionwith sleep phases, body position, hydration, and time, which in itselfcan reveal one's quality of sleep and habits at night. A temperaturesensor can be, e.g., a diode type sensor, an external low-powertemperature sensor such as the Texas Instruments LM94022 multi-gainsensor, or other appropriate type of temperature sensor. The temperaturesensor can be operable to record oral temperatures, thereby providingpotential heat-related oral and general health of a user. In someaspects, the temperature sensor can be an integrated humidity andtemperature sensor. Such integrated sensor can include, e.g., the HDC1080 sensors from Texas Instruments.

In some aspects, the device comprises a microphone or vibration sensor.A microphone or vibration sensor can be useful in detecting breathingpatterns during sleep. The human breath soundwaves can provideinformation related to breathing conditions such as sleep apnea andsnoring. The microphone/vibration sensor can be a unit similar to thatof a 801S Vibration Sensor Module vibration Analog Output SensitivityLM393 within the mainstream market. In some aspects, the microphone orvibration sensor is enclosed in an acoustic chamber in the body of thedevice. In some aspects, the microphone/vibration sensor is at theproximal end in the body of the mouthguard in an acoustic chamber thatcollects the soundwave of the human breath. In some aspects, themicrophone/vibration sensor is in a protective compartment as describedfurther below, wherein the protective compartment collects the soundwaveof the human breath.

In some aspects, the device comprises a nine-axis inertial sensorenclosed in the body of the mouthguard. The inertial sensor comprises athree-axis magnetometer, a three-axis accelerometer, and a three-axisgyroscope, the three-axis magnetometer operable to provide a referenceplane in relation to the earth's magnetic field for the three-axisaccelerometer and the three-axis gyroscope. The nine-axis inertialsensor is adapted to sense the position and movement of the head andbody of a subject wearing the device. Within the field, accelerometershave been used to detect impact during athletic activities, most notablywithin a football helmet that is connected to a mouthguard. In someaspects, the inertial sensor is located in the body of the mouthguard,at the proximal end of the mouthguard. Use of an inertial sensor in adevice of the instant disclosure can detect the sudden/gradual movementof the head, the body, or both. For instance, the inertial sensor cantrack if an individual is upright, sleeping sideways, on back, or onbelly which plays a large role with numerous medical and psychologicalindicators and patterns such as nightmares, stress, PTSD, or sleepapnea.

The device comprises a controller in the body of the mouthguard. Thecontroller is in functional communication with the two or more sensors,and is operable to receive and communicate sensor data. In addition toreceiving sensor data, the controller can include additional inputcomponents that permit input by a user (e.g., a touch screen display, akeyboard, a keypad, a mouse, a button, a switch, a microphone, etc.).The controller can also include output components that provide outputinformation (e.g., a display, a speaker, one or more light-emittingdiodes (LEDs), etc.).

The device further comprises a means for communication enclosed in thebody of the device. The means for communication is operable to receivethe sensor data from the controller and communicate the sensor data to asecondary device. The means for communication may include atransceiver-like component (e.g., a transceiver, a separate receiver andtransmission source, etc.) that communicates the sensor data received bythe controller to a secondary device, such as via a wireless connectionusing a wireless communication protocol, a wired connection, or acombination of wired and wireless connections. A wired connection caninclude an Ethernet interface, an optical interface, a coaxialinterface, an infrared interface, a universal serial bus (USB)interface, and/or the like. A wireless communication protocol caninclude an NFC communication, a Radio-frequency identification (RFID)communication, Bluetooth, LTE, ZigBee, LoraWAN, Wi-Fi, and/or the like.In some aspects, the means of communication comprises a transmitteroperable to communicate the oral data to the secondary device wirelesslyusing a wireless communication protocol. In some aspects, the means ofcommunication comprises a transmitter operable to communicate the oraldata to the secondary device wirelessly using Bluetooth.

The secondary device can be a stationary computing device such as adesktop computer. Alternatively, the secondary device can be a mobilecomputing device such as a cellular phone (e.g., a smartphone orstandard cellular phone), a portable computer (e.g., a tablet computer,a laptop computer, etc.), a wearable device (e.g., a watch, a pair ofglasses, a lens, clothing, and/or the like), a personal digitalassistant (PDA), a computing device with no user interface, a cloudcomputing platform, and/or other like devices.

The device further comprises a power source functionally coupled to thecontroller and the two or more sensors. The power source can be a wiredconnection to an external power source. For instance, the power sourcecan be rechargeable through a port defined in the device. The powersource can also be a power storage device such as a conventionalbattery, capacitor, or electromagnetic power source. The power sourcecan be removable, replaceable, rechargeable, and combinations thereof.For instance, if the power source is rechargeable, the power source canbe rechargeable wirelessly or through a wired connection to an externalpower source. The power source can also be rechargeable by an electricgenerator that is powered by mechanical energy received from thesubject. In this aspect, the electric generator can be configured toconvert mechanical energy applied to the mouth guard by the subject(through, for example, biting down) into electrical energy.

In addition to the controller, the device can further comprise at leastone processor and associated memory adapted to receive sensor data fromthe controller. In some aspects, the processor can be operable to assignone or more event times, wherein each event time indicates the time of achange in the state of a signal received from a sensor. In this aspect,the associated memory can be operable to receive and store the signalsand/or outputs of the sensors of the device, and the one or more eventtimes. The storage component may store information and/or softwarerelated to the operation and use of the controller. The storagecomponent can include a random-access memory (RAM), a read only memory(ROM), and/or another type of dynamic or static storage device (e.g., aflash memory, a magnetic memory, an optical memory, etc.) that storesinformation and/or instructions for use by the controller.

In some aspects, it is contemplated that the processor can comprisemeans for generating an alarm in response to one or more inputs from asensor. In these aspects, it is contemplated that the means forgenerating an alarm can comprise a conventional device for selectivelygenerating optical, thermal, vibrational, and/or audible alarm signals.

Other components that may be included in the device can be a powerbutton, controls for operating one or more components of the device, acomponent that provides output information from the controller (e.g., adisplay, a speaker, one or more light-emitting diodes (LEDs), etc.), orcombinations thereof. For instance, when the means for communication isa Bluetooth module, the controls can be used to connect and pair thedevice to the secondary device. In some aspects, the power button canalso be used as a means for controlling one or more of the components ofthe device.

It will be recognized that one or more of the components of the device,including the one or more sensors, the controller, the means forcommunication, the power source and any other electronic components, canbe integrated onto a single circuit board for space saving. Further, oneor more of the one or more sensors, the controller, the means forcommunication, the power source and any other electronic components canbe enclosed in a protective compartment in the body of the mouthguard.For instance, the protective compartment can be water resistant, and canprotect the components from biting forces and from the environment inthe oral cavity, including saliva. The protective compartment can besealed or can comprise a resealable opening for access to thecomponents. In some aspects, one or more components of the device,including sensors, controllers, and communication means, are enclosed ina protective compartment in the mouthguard. In some aspects, when theprotective compartment comprises a microphone/vibration sensor, theprotective compartment is operable to provide an acoustic chamber thatcollects the soundwave of the human breath.

Referring to FIG. 1 and FIG. 2, shown is a graphical representationillustrating an aspect of the oral data collection device 100. Thedevice 100 comprises a mouthguard 110, the mouthguard comprising anarch-shaped body 120, a proximal end 130, a first distal end 140 a, anda second distal end 140 b, an external surface 150, and an internalsurface 160. The mouthguard 110 further comprises a first biting surface170 (not shown in FIG. 2) and a tray 180 operable to enclose a user'supper or lower teeth, the tray comprising a second biting surface 190(not shown in FIG. 1) opposite the first biting surface 170.

Referring now to FIGS. 3-7, the device 100 comprises a first pressuresensor 200 a in the body 120 of the device 100 at the first distal end140 a and a second pressure sensor 200 b at the second distal end 140 bof the body 120. Each sensor is operable to sense biting force exertedby the upper and lower molars of the subject at the first biting surface170 and second biting surface 190. In one alternative aspect of thedevice shown in FIGS. 6 and 7, the device comprises a first pressuresensor stack 200 a comprising a first pressure sensor 200 c and a secondpressure sensor 200 d, and a second pressure sensor stack 200 bcomprising a first pressure sensor 200 e and a second pressure sensor200 f.

The device further comprises a humidity sensor 210 comprising a sensingsurface 220. The sensing surface 220 is exposed at right of center ofthe internal surface 160 of the mouthguard 110. Electronic components230 of the humidity sensor 210 are enclosed in the protectivecompartment 240 of the mouthguard 110.

The device 100 further comprises a controller 250 in the protectivecompartment 240 of the mouthguard 110, a Bluetooth module 260 forcommunicating the sensor data received by the controller 250, and abattery 270 to power the device. In this aspect, the device furthercomprises a nine-axis sensor 280 and a microphone/vibration sensor 290.

II. Methods

Another aspect of the present disclosure encompasses methods ofcollecting oral data in the oral cavity of a subject. In a method of theinvention, the device is worn by the subject by positioning the devicein engagement with at least one of the upper teeth or the lower teeth ofthe subject. In some aspects, the device is worn by the subject duringsleep. In other aspects, the device is worn by the subject duringexercise. In operation, it is contemplated that data points can becollected and then processed according to a predetermined algorithm,such as a series of equations and/or lookup tables. For instance, thedata can be used to assign one or more event times, wherein each eventtime indicates the time of a change in the state of a signal receivedfrom a sensor. Further, data points collected and/or assigned eventtimes can be translated into health score using a predeterminedalgorithm.

The collected oral data or the event times or health score derived fromthe data can be used in determining a personalized treatment protocol,staging a given health condition, measuring response to therapy,phenotyping for selection to participate in drug trials, measuringstability of an anatomical structure, or predicting rate of change ofthe given disease in a subject in need thereof. The subject has or issuspected of having one or more health conditions in the oral cavity ora health condition exhibited in the oral cavity. As used herein, theterm “exhibited in the oral cavity” refers to symptoms of healthconditions in the subject other than health conditions in the oralcavity, but can be detected using biometric data collected in the oralcavity. Non-limiting examples of health conditions include concussionsand head injuries, bruxism, xerostomia, sleep apnea, nightmares, PTSD,anxiety, insomnia, tooth infection, tooth decay, tooth damage, andpsychological disorders such as psychosis, sleep walking, andcombinations thereof among other disorders. In some aspects, the healthcondition is bruxism. In other aspects, the health condition isxerostomia.

The method further comprises using the oral cavity data collected fromthe subject to develop a database of biometric measurements obtainedfrom the subject alone or in combination with data measurements obtainedfrom other subjects, for providing information to the subject orhealthcare provider regarding historical physiological characteristicsof the subject, thereby providing a means for determining healthconditions and unusual behaviors. The collected data can be used incombination with descriptive information comprising one or more dataelements relating to the subject. The data elements can include theresults of clinical tests normally performed during a regular visit bythe subject to a physician, including weight, height, blood pressure,pulse, and results of blood tests such as cholesterol levels,comprehensive metabolic panel, and lipid panel, among others. The dataelements can also include information and results of clinical testsobtained during diagnosis of a health condition. For instance, when thehealth condition is bruxism, non-limiting examples of data elements caninclude tooth wear, headaches, anxiety, jaw pain, abnormal sleepingpatterns, changes in sleep positioning, changes in bite forcedistribution, changes in movement while sleeping, sleep loss, behavioralchanges (e.g., heightened stress, anxiety), and combinations thereof.

III. Computer-Implemented Methods and Systems

One aspect of the present disclosure encompasses a computer-implementedmethod for collecting biometric data in the oral cavity of a subject.The method comprises providing an oral data collection device of SectionI, and a computer system having at least one processor and associatedmemory comprising instructions to process the oral data collected by thedevice. The computer system having at least one processor and associatedmemory can be a processor further comprised in the device.Alternatively, the computer system can be a secondary device. The deviceand data points and methods of processing the data points can be asdescribed above in Sections I and II. The computer system comprisesinstructions to receive at least one data point from the device, andprocess the at least one data point according to a predeterminedalgorithm, such as a series of equations and/or lookup tables.

Another aspect of the present disclosure encompasses at least onenon-transitory computer readable medium. The medium stores instructionswhich, when executed by at least one processor, cause the at least oneprocessor to receive at least one data point from the device, andprocess the at least one data point according to a predeterminedalgorithm, such as a series of equations and/or lookup tables.

The medium can further comprise instructions, which when executed by theat least one processor, cause the at least one processor to display theprocessed at least one data point. Further, the medium can also compriseinstructions, which when executed by the at least one processor, causethe at least one processor to generate a report of the processed atleast one data point.

Yet another aspect of the present disclosure encompasses a system forcollecting biometric data in the oral cavity of a subject. The systemcomprises an oral data collection device collecting biometric data inthe oral cavity of the subject. The device and data points and methodsof processing the data points can be as described above in Sections Iand II. The system further comprises a processor. The processorcomprises a memory having instructions stored thereon, wherein theinstructions, when executed by the processor, cause the processor toperform the methods disclosed herein. In one aspect, the system alsocomprises an interface unit to display an output wherein the output isused for at least one of determining a personalized treatment protocolfor the subject, staging the given disease in a patient, measuringresponse to therapy, phenotyping for patient selection to participate indrug trials, measuring stability of an anatomical structure, orpredicting rate of change of the given disease. The interface unit maybe, for example, a display device such as, but not limited to a CRT(cathode ray tube) or LCD (liquid crystal display) monitor. The displaydevice can display information to the user and may include or be inoperative communication with an input device such as a keyboard,touchscreen, and/or pointing device (e.g., a mouse or a trackball). Aninput device may alternatively, or in addition, be configured to receiveand transmit a signal based on other types of user input, such as voiceinstruction, or body movement.

In some aspects, the processor is further configured by way ofprocessor-executable instructions to obtain descriptive informationrelating to the subject, the descriptive information comprising one ormore data elements. The descriptive information can be as described InSection II above.

It should be understood that the disclosed methods, method steps and/orprocessor-executable instructions can be implemented or executed bymeans of any digital electronic system, computer hardware, firmware,software, or any combinations thereof. A processor may take the form ofa programmable processor, a computer, or multiple computers, which maybe programmed to perform the disclosed methods using any programminglanguage. A program of instructions may comprise a stand-alone programor may have two or more modules, components, subroutines, or the like asknown in the art of computer programming. Method steps can be performedby one or more programmable processors executing a computer program toperform functions or aspects of the methods, by operating on input dataand generating output information.

A processor may be configured, by way of processor-executableinstructions, to receive instructions and data from a memory device,which can be configured for storing instructions and data. A processor,or a computer containing a processor, may be in operative communicationwith at least one or more mass storage devices for storing data (e.g.,magnetic, magneto-optical disks, or optical disks), such that theprocessor can receive data from or transfer data to such storagedevice(s). For example, data and/or instruction communications can beperformed over a digital communications network.

It should be further understood that the disclosed methods, method stepsand/or processor-executable instructions can be performed by adistributed computing system. A distributed computing system includes,for example, a front-end (user-end) interface, middleware, and aback-end, or any combination of two or more of these elements. Afront-end component can be, for example, a client computer configured byway of processor-executable instructions to display a graphical userinterface through which a user can interact with and provide input tothe system. An interface can be embodied in a Web browser interface. Amiddleware component can be, for example, an application server. Aback-end component can be, for example, a data server. Any or all of thecomponents of such a distributed system can be in operativecommunication by way of one or more digital communications networks,which may be wired and/or wireless networks.

DEFINITIONS

Unless defined otherwise, all technical and scientific terms used hereinhave the meaning commonly understood by a person skilled in the art towhich this invention belongs. The following references provide one ofskill with a general definition of many of the terms used in thisinvention: Singleton et al., Dictionary of Microbiology and MolecularBiology (2nd ed. 1994); The Cambridge Dictionary of Science andTechnology (Walker ed., 1988); The Glossary of Genetics, 5th Ed., R.Rieger et al. (eds.), Springer Verlag (1991); and Hale & Marham, TheHarper Collins Dictionary of Biology (1991). As used herein, thefollowing terms have the meanings ascribed to them unless specifiedotherwise.

When introducing elements of the present disclosure or the preferredaspects(s) thereof, the articles “a”, “an”, “the” and “said” areintended to mean that there are one or more of the elements. The terms“comprising”, “including” and “having” are intended to be inclusive andmean that there may be additional elements other than the listedelements.

As used herein, the terms “communication” and “communicate” may refer tothe reception, receipt, transmission, transfer, provision, and/or thelike, of information (e.g., data, signals, messages, instructions,commands, and/or the like). For one unit (e.g., a device, a system, acomponent of a device or system, combinations thereof, and/or the like)to be in communication with another unit means that the one unit is ableto directly or indirectly receive information from and/or transmitinformation to the other unit. This may refer to a direct or indirectconnection (e.g., a direct communication connection, an indirectcommunication connection, and/or the like) that is wired and/or wirelessin nature. Additionally, two units may be in communication with eachother even though the information transmitted may be modified,processed, relayed, and/or routed between the first and second unit. Forexample, a first unit may be in communication with a second unit eventhough the first unit passively receives information and does notactively transmit information to the second unit. Alternatively, a firstunit may be in communication with a second unit if at least oneintermediary unit (e.g., a third unit located between the first unit andthe second unit) processes information received from the first unit andcommunicates the processed information to the second unit.

As used herein, the term “computing device” may refer to one or moreelectronic devices that are operable to directly or indirectlycommunicate with or over one or more networks. The computing device maybe a mobile device. As used herein, the term “mobile device” may referto one or more portable electronic devices operable to communicate withone or more networks. As an example, a mobile device may include acellular phone (e.g., a smartphone or standard cellular phone), aportable computer (e.g., a laptop computer, etc.), a wearable device(e.g., a watch, pair of glasses, lens, clothing, and/or the like), aportable computer with no user interface, a personal digital assistant(PDA), and/or other like devices. The computing device may also be adesktop computer. Furthermore, the term “computer” may refer to anycomputing device that includes the necessary components to receive,process, and output data, and normally includes a display, a processor,a memory, an input device, and a network interface.

As used herein, the term “application” or “application programinterface” (API) refers to computer code, a set of rules, or other datasorted on a computer-readable medium that may be executed by a processorto facilitate interaction between software components, such as aclient-side front-end and/or server-side back-end for receiving datafrom the client. An “interface” refers to a generated display, such asone or more graphical user interfaces (GUIs) with which a user mayinteract, either directly or indirectly (e.g., through a keyboard,mouse, etc.).

As various changes could be made in the above-described cells andmethods without departing from the scope of the invention, it isintended that all matter contained in the above description shall beinterpreted as illustrative and not in a limiting sense.

What is claimed is:
 1. An oral data collection device, comprising: a. amouthguard, the mouthguard comprising: i. an arch-shaped body comprisinga proximal end, a first distal end, and a second distal end, an externalsurface, an internal surface, a first biting surface, and a trayoperable to engage the upper or lower teeth of a subject, the traycomprising a second biting surface opposite the first biting surface; b.sensors in the body of the mouthguard, the sensors comprising: i. afirst pressure sensor stack at the first distal end of the mouthguardand a second pressure sensor stack at the second distal end of themouthguard, wherein each pressure sensor stack comprises a firstpressure sensor and a second pressure sensor arranged in a stack; ii. ahumidity sensor operable to sense relative humidity in the breath of auser wearing the device; and iii. a microphone or vibration sensor; c. acontroller in the body of the mouthguard, wherein the controller is infunctional communication with the sensors, and wherein the controller isoperable to receive and communicate sensor data; d. a means forcommunication in the body of the mouthguard, wherein the means forcommunication is operable to receive the sensor data from the controllerand communicate the sensor data to a secondary device; and e. a powersource functionally coupled to the controller and the one or moresensors; wherein each pressure sensor is a force plate pressure sensor,and wherein the controller is configured to receive data from eachpressure sensor, and extrapolate the received data to obtain velocity ofmovement (m/s), power (Watts), displacement (Meters), temporalparameters (seconds), and left/right asymmetry for bilateral systems. 2.The device of claim 1, wherein each pressure sensor is operable tomeasure shear forces.
 3. The device of claim 1, wherein the first sensorof each pressure sensor stack is operable to sense the biting pressureof a bottom molar, and the second sensor of each pressure sensor stackis operable to sense the biting pressure of a top molar.
 4. The deviceof claim 1, wherein a sensing surface of the humidity sensor is at theinternal surface off center of the proximal end of the mouthguard. 5.The device of claim 1, further comprising an oxygen sensor, a nine-axisinertial sensor, a pH or other biochemical sensor, or combinationsthereof.
 6. The device of claim 5, wherein the nine-axis inertial sensoris enclosed in the body of the mouthguard, and comprises a three-axismagnetometer, a three-axis accelerometer, and a three-axis gyroscope,the three-axis magnetometer operable to provide a reference plane inrelation to earth's magnetic field for the three-axis accelerometer andthe three-axis gyroscope, wherein the nine-axis inertial sensor isadapted to sense a position and movement of the head and body of a user.7. The device of claim 5, wherein the temperature sensor, humiditysensor, and oxygen sensor are an integrated temperature, humidity, andoxygen sensor.
 8. The device of claim 5, wherein the microphone orvibration sensor is enclosed in an acoustic chamber in the body of themouthguard.
 9. The device of claim 1, wherein the means of communicationcomprises a transmitter operable to communicate sensor data to thesecondary device wirelessly using a wireless communication protocol. 10.The device of claim 1, wherein the secondary device is a desktopcomputer, a mobile computing device, a wearable device, a personaldigital assistant, a computing device with no user interface, a cloudcomputing platform, or a combination thereof.
 11. The device of claim 1,wherein the device further comprises a protective compartment housingone or more of the sensors, the controller, the means for communication,and the power source.
 12. A medical analytics system comprising: a. anoral data collection device of claim 1; and b. a secondary devicecomprising at least one processor and associated memory adapted toreceive sensor data collected by the data collection device, andinstructions which when executed by the at least one processor, causethe at least one processor to: i. interpret the sensor data obtainedfrom a subject into descriptive factors indicative of a health conditionof the subject; and ii. output the descriptive factors.
 13. The systemof claim 12, wherein the descriptive factors indicative of a healthcondition of the subject comprise hydration, breathing patterns, bodytemperature, body and head position, body and head movement, clenchingof the jaws, sleep phase, and nighttime mouth position.
 14. The systemof claim 12, wherein the secondary device further comprises instructionswhich when executed by the at least one processor, cause the at leastone processor to provide a personalized treatment protocol, stage ahealth condition, measure a response to therapy, phenotype for selectionto participate in drug trials, measure stability of an anatomicalstructure, or predict a rate of change of a health condition in thesubject.
 15. A method of determining a personalized treatment protocol,staging a given health condition, measuring response to therapy,phenotyping for selection to participate in drug trials, measuringstability of an anatomical structure, or predicting rate of change of ahealth condition in a subject in need thereof, the method comprising: a.providing or having provided the device of claim 1 to the subject forwearing by the subject during sleep; and b. interpret the sensor dataobtained from the subject into descriptive factors indicative of ahealth condition of the subject to determine the personalized treatmentprotocol, stage the given health condition, measure response to therapy,phenotype for selection to participate in drug trials, measure stabilityof an anatomical structure, or predict rate of change of a given healthcondition in the subject.
 16. The method of claim 15, wherein the methodfurther comprises providing a secondary device comprising at least oneprocessor and associated memory adapted to receive sensor data collectedby the data collection device, and instructions which when executed bythe at least one processor, cause the at least one processor to: a.interpret the sensor data obtained from the subject into descriptivefactors indicative of a health condition of the subject; and b. outputthe descriptive factors.
 17. The method of claim 16, wherein thedescriptive factors indicative of a health condition of the subjectcomprise hydration, breathing patterns, body temperature, body and headposition, body and head movement, clenching of the jaws, sleep phase,and nighttime mouth position.
 18. The method of claim 16, wherein thesecondary device further comprises instructions which when executed bythe at least one processor, cause the at least one processor to providethe personalized treatment protocol, stage the health condition, measurethe response to therapy, phenotype for selection to participate in drugtrials, measure stability of an anatomical structure, or predict therate of change of a health condition in the subject.